The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorisation (EUA) for the Zika Virus RNA Qualitative Real-Time RT-PCR test (Zika RT-PCR test).
The test is the first from a commercial laboratory provider to be approved. Until now, only tests from the Centers for Disease Control and Prevention were authorised, and could only be used in qualified laboratories designated by the CDC.
In contrast, the Zika RT-PCR test – developed by U.S. company Quest Diagnostics – is to be made widely available to all physicians, and is expected to be on the market as soon as next week. The same company received similar authorisation for a commercial lab test for the H1N1 influenza virus during the 2009 pandemic.
EUA authorisation for the Zika RT-PCR test does not represent full FDA clearance or approval. The decision indicates that the test is authorised for the duration of the declaration only, and testing is limited to pre-specified qualified laboratories. Within the United States, positive results must be reported to the CDC.
The CDC recommends RT-PCR testing during the first seven days of symptoms onset for certain patients. A negative result does not preclude infection, and additional serological testing to evaluate the immune response to infection may be considered within 2-12 weeks after symptom onset.
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